Université Lyon 1, Université de Lyon, Lyon, France
Department of Urinary and Vascular Imaging, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France.
BMJ Open. 2022 Feb 9;12(2):e051274. doi: 10.1136/bmjopen-2021-051274.
Prostate multiparametric MRI (mpMRI) has shown good sensitivity in detecting cancers with an International Society of Urological Pathology (ISUP) grade of ≥2. However, it lacks specificity, and its inter-reader reproducibility remains moderate. Biomarkers, such as the Prostate Health Index (PHI), may help select patients for prostate biopsy. Computer-aided diagnosis/detection (CAD) systems may also improve mpMRI interpretation. Different prototypes of CAD systems are currently developed under the Recherche Hospitalo-Universitaire en Santé / Personalized Focused Ultrasound Surgery of Localized Prostate Cancer (RHU PERFUSE) research programme, tackling challenging issues such as robustness across imaging protocols and magnetic resonance (MR) vendors, and ability to characterise cancer aggressiveness. The study primary objective is to evaluate the non-inferiority of the area under the receiver operating characteristic curve of the final CAD system as compared with the Prostate Imaging-Reporting and Data System V.2.1 (PI-RADS V.2.1) in predicting the presence of ISUP ≥2 prostate cancer in patients undergoing prostate biopsy.
This prospective, multicentre, non-inferiority trial will include 420 men with suspected prostate cancer, a prostate-specific antigen level of ≤30 ng/mL and a clinical stage ≤T2 c. Included men will undergo prostate mpMRI that will be interpreted using the PI-RADS V.2.1 score. Then, they will undergo systematic and targeted biopsy. PHI will be assessed before biopsy. At the end of patient inclusion, MR images will be assessed by the final version of the CAD system developed under the RHU PERFUSE programme. Key secondary outcomes include the prediction of ISUP grade ≥2 prostate cancer during a 3-year follow-up, and the number of biopsy procedures saved and ISUP grade ≥2 cancers missed by several diagnostic pathways combining PHI and MRI findings.
Ethical approval was obtained from the Comité de Protection des Personnes Nord Ouest III (ID-RCB: 2020-A02785-34). After publication of the results, access to MR images will be possible for testing other CAD systems.
NCT04732156.
前列腺多参数磁共振成像（mpMRI）在检测国际泌尿病理学会（ISUP）分级≥2 的癌症方面具有较高的敏感性。然而，它的特异性较差，其读者间的可重复性仍处于中等水平。生物标志物，如前列腺健康指数（PHI），可能有助于选择进行前列腺活检的患者。计算机辅助诊断/检测（CAD）系统也可能改善 mpMRI 解读。目前，根据 Recherche Hospitalo-Universitaire en Santé / Personalized Focused Ultrasound Surgery of Localized Prostate Cancer（RHU PERFUSE）研究计划开发了不同原型的 CAD 系统，以解决跨成像协议和磁共振（MR）供应商的稳健性以及癌症侵袭性特征描述能力等挑战性问题。该研究的主要目的是评估最终 CAD 系统的受试者工作特征曲线下面积（AUC）与前列腺成像报告和数据系统 V.2.1（PI-RADS V.2.1）相比，在预测接受前列腺活检的患者中 ISUP≥2 前列腺癌的存在时的非劣效性。
这是一项前瞻性、多中心、非劣效性试验，将纳入 420 名患有疑似前列腺癌、前列腺特异性抗原水平≤30ng/ml 和临床分期≤T2c 的男性。纳入的男性将接受前列腺 mpMRI 检查，并使用 PI-RADS V.2.1 评分进行解读。然后，他们将进行系统和靶向活检。在活检前评估 PHI。在患者入组结束时，将使用 RHU PERFUSE 计划开发的最终版本 CAD 系统评估 MR 图像。主要次要结局包括在 3 年随访期间预测 ISUP 分级≥2 的前列腺癌，以及通过结合 PHI 和 MRI 结果的几种诊断途径节省的活检程序数量和错过的 ISUP 分级≥2 癌症数量。
已获得 Nord Ouest III 保护委员会的伦理批准（ID-RCB：2020-A02785-34）。结果公布后，将可以访问 MR 图像，以测试其他 CAD 系统。
NCT04732156。
